From: An overview of the design and methods for retrieving high-quality studies for clinical care
Purpose category | Methodologic rigor |
---|---|
Etiology | Observations concerned with the relationship between exposures and putative clinical outcomes; Data collection is prospective; Clearly identified comparison group(s); Blinding of observers of outcome to exposure. |
Prognosis | Inception cohort of individuals all initially free of the outcome of interest; Follow-up of ≥ 80% of patients until the occurrence of a major study end point or to the end of the study; Analysis consistent with study design. |
Diagnosis | Inclusion of a spectrum of participants; Objective diagnostic ("gold") standard OR current clinical standard for diagnosis; Participants received both the new test and some form of the diagnostic standard; Interpretation of diagnostic standard without knowledge of test result and vice versa; Analysis consistent with study design. |
Treatment | Random allocation of participants to comparison groups; Outcome assessment of at least 80% of those entering the investigation accounted for in 1 major analysis at any given follow up assessment; Analysis consistent with study design. |
Economics | Question is a comparison of alternatives; Alternative services or activities compared on outcomes produced (effectiveness) and resources consumed (costs); Evidence of effectiveness must be from a study of real patients that meets the above-noted criteria for diagnosis, treatment, quality improvement, or a systematic review article; Effectiveness and cost estimates based on individual patient data (micro-economics); Results presented in terms of the incremental or additional costs and outcomes of one intervention over another; Sensitivity analysis if there is uncertainty. |
Clinical Prediction Guide | Guide is generated in one or more sets of real patients (training set); Guide is validated in another set of real patients (test set). |
Review articles | Statement of the clinical topic; Explicit statement of the inclusion and exclusion criteria; Description of the methods; ≥ 1 article must meet the above noted criteria. |